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N6-Dm-13-02-000-01a-10
EUDAMEDClass IIa (EU MDR)
Ref N6-DM-13-02-000-01A-10Model N6
Identity
- Model / Reference
- N6 EUDAMEDN6-DM-13-02-000-01A-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800091150316 EUDAMED
- Basic UDI-DI
- B-08800091150316 EUDAMED88000911nugabestN4AJ EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMEDZ120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
N6-Dm-13-02-000-01a-10 by Nuga Medical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800091150316 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800091150316 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nuga Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000026434
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 6439df81-d555-42f5-8b4c-0a89f0d7697e 61 fields · synced Jul 22, 2026
- EUDAMED 70b546ce-e476-423e-b871-56662e5b7850 61 fields · synced May 17, 2026